FDA DevicesClass II
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator...
Published: July 8, 2026Recall ID: Z-2640-2026Category: devicesCountry: US
Reason for Recall / Hazard
In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing.
Product Description & Identification
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Additional Source Details
| Field | Value |
|---|---|
| City | Madison |
| State | WI |
| Event id | 99075 |
| Address 1 | 1240 Deming Way |
| Address 2 | N/A |
| Code info | All systems prior with software version 11X that utilize the Exchange Table |
| Postal code | 53717-1954 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 48 units |
| Reason for recall | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room control pendant, the collimator may release and fall from the housing. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260616 |
| Initial firm notification | Letter |
| Center classification date | 20260701 |
Overview
- Recalling FirmAccuray Incorporated
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of China, Colombia, Czech Republic, France, Hong Kong, Japan, Korea, Republic of, Latvia, Mexico, Myanmar, Saudi Arabia, Taiwan, Turkey, Ukraine.